Arbabi-Kalati, F., Arbabi-Kalati, F., Deghatipour, M., & Ansari Moghadam, A. (2012). Evaluation of the Efficacy of Zinc Sulfate in the Prevention of Chemotherapy-Induced Mucositis: A Double-Blind Randomized Clinical Trial, Archives of Iranian Medicine, 15(7), 413-417.

To evaluate the effects of oral zinc sulfate on prevention of mucositis, xerostomia, and pain induced by chemotherapy.

Patients were divided by block randomization into two groups of zinc sulfate and placebo. Patients were informed about oral hygiene and associated care. Patients in the intervention group took three 220 mg zinc sulfate capsules daily until the end of chemotherapy treatment. The placebo group took three placebo capsules that were similar in shape, taste, and color to the zinc sulfate capsules. Randomized divisions and zinc sulfate drug prescription of patients were carried out by patients’ oncologists. Patients' mucous and salivary health was checked by an oral medicine specialist and dental student prior to the initiation of chemotherapy, two weeks after initiation of chemotherapy, and every two weeks until the end of chemotherapy. The specialist and dental student were blinded to the randomization and treatment.

The study was comprised of 50 adult patients over the age of 18.

MALES 52%, FEMALES 48%

OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria were chemotherapy treatment by a regimen with the same mucositis probability, including cyclophosphamide, doxorubicin, dacarbazine, gemcitabine, methotrexate, and 5-fluorouracil. Exclusion criteria included previous or simultaneous radiotherapy in the head and neck region, including the nasopharynx, oropharynx, and larynx, previous head and neck surgery due to malignancy, use of dentures, pregnancy, and infection.  

 

SITE: Single site

LOCATION: Oncology Department at Zahedan Imam Ali Hospital, Zahedan, Iran

PHASE OF CARE: Multiple phases of care

APPLICATIONS: Late effects and survivorship elderly care, end-of-life and palliative care
 

A double-blind, randomized study where subjects were divided by block randomization into two groups of zinc sulfate and placebo.

• Oral mucositis was graded from 0 to 4, using World Health Organization (WHO) criteria.  
• Xerostomia was diagnosed from 1 to 4 using the LENT SOMA scale.  
• The degree of pain was evaluated based on a visual analog scale.
• For quality of life, patients individually met with the dental student at each follow-up, and the student completed the EORTC LQ-OES18.
   

Xerostomia: Baseline of all patient’s salivary flows were within normal range, p = 0.13. At the first visit (during the second week of chemo), no significant differences in xerostomia were seen between groups p = 0.019. At the second visit (during the fourth week of chemo), the intensity of xerostomia in the drug group was less than the placebo, p < 0.005, and this trend continued in the 8th and 16th weeks of treatment. At the beginning of the study, none of the patients had symptoms of mucositis. During the frst, second, and third visits, there were no significant differences in mucositis intensity between groups. At weeks 8, 12, and 16 of chemo, there were significant differences between both groups. The intervention group had less intensity than the placebo group, p < 0.005. Regarding pain intensity from the third visit (wk 6 chemo) until the 10th visit (wk 20), there were significant differences between groups, indicating that pain intensity in the drug groups was less than in the placebo groups, p < 0.005.

Recovery: Mucosiits recovery period is the time interval between appearance of mucositis s/s and complete resolution. The recovery period was seven weeks and three days for the zinc treatment group and eight weeks for the placebo group, p = 0.13.

Xerostomia recovery period for xerostomia was from the time of appearance of the s/s and the complete resolution. Seven weeks in the placebo groups versus six weeks and five days in the zinc group, no significant difference was noted between the groups, p = 0.23.
 

The use of zinc sulfate was able to decrease the intensity of xerostomia, mucositis, and pain in patients that develop chemotherapy induced mucositis. There was no difference between the incidence of mucositis or delay in developing mucositis between the zinc sulfate and placebo group. The recovery period for xerostomia to complete resolution was not statistically significant between groups.

• Small sample <100
• It is not clear whether the 50 initial participants were all studied for the entire duration. There is no mention of dropouts. No information is available on patient adherence to doses and oral care plan.
   

The use of zinc sulfate might decrease the intensity of mucositis, which could help with patient compliance with treatment, affect weight loss from poor nutrition, and decrease the need for hydration.